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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Event Detail

Event ID 67017
Product Type Devices
Status Ongoing
Recalling Firm Brainlab AG
City Feldkirchen
Country DE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy. Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032 Class II Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient's body, potentially leading to infection and serious injury. 25 units Z-0967-2014